510(k) · Cleared
ClearedCLARO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clrs Technology Corporation · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Apr 15, 2010 as substantially equivalent to K080638 (Clrs Technology Corporation, 2008) and 4 other predicates after a 391-day review. Its family tree reaches back 10 generations to 1995. 1 later device descends from it.
- Decided
- Apr 15, 2010
- Review
- 391 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K943450 (1995). 102 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- This deviceK090744 CLAROClrs Technology Corporation · 2010
- Descendant · cites it directly · 0 of its ownK150282 Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- This deviceK090744 CLAROClrs Technology Corporation · 2010
Most influential descendants
Showing 1 of 1 · See all- K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −1 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| 0 (this device) | K090744 | CLARO | Clrs Technology Corporation | 2010 | — |
| +1 | K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | Shaser, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080638 | CLAROSummary page 1…Instrument, Surgical, Powered Regulatory Class: Class II Product Code: OLP 3. Predicate Devices CLARO (K080638) Zeno Acne Device (K043377) ThermaClear (K060653) Tanda (K080591) Clear-U (KOS81307) 4. Device De… | 2008 |
| * | K043377 | ZENOSummary page 1…Regulatory Class: Class II Product Code: OLP 3. Predicate Devices CLARO (K080638) Zeno Acne Device (K043377) ThermaClear (K060653) Tanda (K080591) Clear-U (KOS81307) 4. Device Description The CLARO is a p… | 2005 |
| * | K060653 | ThermaclearSummary page 1…Class II Product Code: OLP 3. Predicate Devices CLARO (K080638) Zeno Acne Device (K043377) ThermaClear (K060653) Tanda (K080591) Clear-U (KOS81307) 4. Device Description The CLARO is a portable handheld intense puls… | 2006 |
| * | K080591 | Tanda Skincare System, Model: PtscsSummary page 1…Product Code: OLP 3. Predicate Devices CLARO (K080638) Zeno Acne Device (K043377) ThermaClear (K060653) Tanda (K080591) Clear-U (KOS81307) 4. Device Description The CLARO is a portable handheld intense pulse light (JPL) device po… | 2008 |
| * | K081307 | Omnilux Clear-U | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 102 ancestors have a recall of any class.
- Of its descendants, K150282 (Shaser, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090744: CLARO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090744
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026